Working Group Single-Use Technologies for Bio-Based Applications

Single-use systems for upstream and downstream processing have become established in many biotechnological processes in recent years, whether in small to medium-scale production, in pre-culture management or in the laboratory. The systems available on the market enable new production facilities to be established quickly for many applications at significantly lower investment costs. In addition, they can be more space-saving, more flexible and even more resource-efficient. At the same time, single-use systems have a wide variety of designs and can also be used in many other biotechnological applications beyond the traditional areas of use in biopharmaceutical production.

Current topics are

• the use of single-use technologies for the production of cell and gene therapeutics and process design
• the procedural characterization and optimization of single-use systems for a variety of new applications in biotechnology, such as pre-culture and continuous processes and cellular agriculture
• the integration of process analytical technologies in single-use systems
• material evaluation, the use of new, environmentally friendly materials and life cycle assessments of single-use based products and bioprocesses.

Publications

Stellungnahme der DECHEMA-Fachgruppe Single-Use-Technologien für biobasierte Anwendungen zum Vorschlag der Beschränkung von PFAS der ECHA

(June 2023)

In February 2023, the ECHA (European Union Chemicals Agency) presented a proposal to restrict the use of per- and polyfluoroalkyl substances (PFAS). According to this proposal, the production and use of more than 10,000 persistent chemicals in these substance classes is to be banned with a transitional period until 2026/27. The expert group Single-Use Technologies for Bio-based Applications has drawn up a statement on this. This has already been submitted by DECHEMA to the ECHA in the consultation process and forwarded to the Federal Ministry of Health and the Federal Ministry for the Environment, as well as to the UBA, VfA, BPI and VDMA for information.

Recommendations for process engineering characterisation of single-use bioreactors and mixing systems by using experimental methods;  Supplement to the 2nd edition:
Volumetric mass transfer coefficient of CO₂

(Oktober 2020)

The supplement to the recommendations for process engineering characterisation (2020, download see publication below) provides  experimental methods for a further important parameter, the k_La(CO₂).
The publication is supplemented by a respective calculation tool.

Download Calculation Tool

Recommendations for process engineering characterisation of single-use bioreactors and mixing systems by using experimental methods (2^nd Edition) (Dezember 2020)

These recommendations provide suitable experimental methods for the process engineering characterisation of single-use bioreactors and mixers. The methods are applicable to a broad range of single-use systems and applications, and can also be used for the engineering characterisation of reusable systems. This 2^nd Edition of recommendations published 2016 is completely revised and the described methods are improved.

The publication is supplemented by a calculation tool for volumetric mass transfer coefficient (k_La), oxygen transfer rate and oxygen uptake rate.

Technical State-of-the-Art and Risk Analysis on Single-Use Equipment in Continuous Processing Steps (März 2020)
A systematic risk analysis and prioritization through a failure mode and effects analysis (FMEA) is performed for a monoclonal antibody process at 500 L production scale. For every upstream and downstream processing step, the technical state-of-the-art, most prominent risks and mitigation strategies are discussed. The mitigation strategies summarize suggestions from industrial and academic end-users, as well as suppliers and take statements from regulatory authorities and existing guidelines from further industry collaborations into consideration

Recommendation for biological evaluation of bioreactor performance for microbial processes September 2019 (2. überarbeitete Auflage)

A process engineering characterization often only provides information about the ideal bioreactor design or scale-up. The Escherichia coli model process described in the recommendation also makes it possible to characterize the biological performance of a system.
The associated Excel tool offers the possibility of a standardized and uniform evaluation of experiments to enable a comparison across bioreactor systems.
If you have any questions about the model process and evaluation, please contact the corresponding author of the recommendation directly.

Auswertungs-Tool zum Download (Excel, 4 MB)

Status Paper "Facility of the Future" (English Version) März 2018

Statuspapier "Facility of the Future" (deutsch, September 2017)

Single-Use-Technologie von A-Z (Januar 2016, Online)

Die web-basierte Mini-Enzyklopädie „Single-Use-Technologie von A-Z“ erklärt wichtige und häufig gebrauchte Fachtermini des Themenkreises Single-Use-Systeme unter Berücksichtigung der aktuellen Hauptanwendungen (German only).

Empfehlung für Leachable-Studien - Standardisierter Zellkulturtest zur Identifizierung kritischer Filme (Januar 2014)Recommendation for Leachables Studies - Standardized cell culture test for the early identification of critical films (Januar 2014, English Version

This recommendation is quoted in ASTM Standard Guide for Cell Culture Growth Assessment of Single-Use Material (E3231 – 19;  Oktober 2019).